CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Polydioxanone (PDS) plates +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01225250
NCT01225250N/ACompleted
CompareCT.gov

An Open-Label, Randomized, 2-Arm Parallel Study Comparing the Efficacy, Ease of Use, and Safety of PDS Plated Cartilagenous Grafting Versus Non-Plated Cartilagenous Grafting as Performed Through Endonasal Rhinoplasty

DeNova Research·interventional·Posted Oct 20, 2010·Updated Nov 4, 2020

In Brief

A clinical study evaluating Polydioxanone (PDS) plates and Caudal septal extension graft performed through endonasal rhinoplasty for Rhinoplasty. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is to determine efficacy, safety, and ease of cartilaginous grafting using polydioxanone (PDS) plates in comparison to non-plated cartilaginous grafts as performed through an endonasal rhinoplasty approach in patients requiring a caudal septal extension (CSE) graft.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhinoplasty
CountriesUnited States
CollaboratorsMentor Worldwide, LLC

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 20, 2010
Enrollment StartNov 24, 2010
Primary CompletionJan 19, 2015
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 15.7 years ago

Interventions

Polydioxanone (PDS) platesdevice

0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.

Caudal septal extension graft performed through endonasal rhinoplastyprocedure

The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.

Caudal septal extension graft performed through endonasal rhinoplastyprocedure

The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.